A Novel Cleansing Solution for High-Quality Upper Gastrointestinal Endoscopy: A Multicenter Randomized Controlled Trial

Abstract

BACKGROUND AND AIMS

Esophagogastroduodenoscopy (EGD) is the gold standard examination for upper gastrointestinal (GI) disease diagnosis; however, intraluminal bubbles and mucus may reduce visibility. Mucolytic and tensioactive agents before EGD improve gastric visualization. We compared the efficacy of a novel cleansing preparation vs fasting on upper GI tract visualization during EGD.

METHODS

We conducted a multicenter, prospective, randomized controlled trial on consecutive adult outpatients undergoing EGD. Patients were randomized 1:1 to drink 50 mL of simethicone 150 mg, N-acetylcysteine 250 mg, and 10% acetic acid solution (Lumevis, Biofarmatec srl, Palermo, Italy) before the EGD or to fasting. The primary outcome was overall mucosal vision quality score, defined as the sum of 1-10 visual analog scale scores (0 = no visualization; 10 = perfect visualization) for each segment (esophagus, stomach, and duodenum) before washing. Secondary outcomes included adverse event rate, patient satisfaction, and EGD duration.

RESULTS

Patients were randomized to cleansing solution (n = 60) or fasting (n = 60). Cleansing preparation administration before EGD was associated with a higher overall mucosal vision quality score compared with fasting only (median visual analog scale score 23 [range, 21-25] vs 19 [range, 16-23], P = 0.001). No adverse events were reported in both groups. Patient satisfaction and EGD duration were similar between the cleansing preparation and fasting only.

CONCLUSION

Compared with fasting only, the administration of this novel cleansing solution was associated with improved mucosal visualization of the upper GI tract.